Senior SSU- Remote opportunities (propharmagroup)

ProPharma are looking for an experience study start up professional to join our growing business & help on newly awarded work. To be successful in this role you have experience leading study start ups for a minimum of 5 years.

The Senior Study Start Up Lead position is responsible for all SSU-related activities in the country/region, on assigned studies, overseeing and leading SSU activities and/or SSU teams in collaboration with other clinical research stakeholders.

Essential Functions: 

• Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures.  

• Manages both the technical and operational aspects of site identification, site feasibility and site activation for assigned projects, site contracts, and project teams. 

• Maintains and analyzes study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement.  

• Executes all start-up activities prior to site activation on assigned studies, according to standards and aligned with study/project requirements and timelines.  

• Prepares country level Informed Consent Form (ICF) and obtains ethics committees' and local regulatory authorities' approval. Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country. 

• Partners with other study team members to provide guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations.  

• Supports drug label preparation and approval (as local label representative) for studies in collaboration with local Regulatory /Quality department, as required.  

• In collaboration with Clinical Site Manager, identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required.  

• Responsible for study budget and contracts negotiation in collaboration with Legal team, as required and ensures compliance with Fair Market Value (FMV) in the country. 

Skills and experience required:

• 5+ years’ experience within a Clinical Research, Site Activation, and Study Start Up. 

• Must be able to prioritize and manage multiple projects and show attention to detail. 

• Comprehensive knowledge and understanding of ICH-GCP  

• Working knowledge and experience in Microsoft Office (e.g., Word, Excel, Project) 

• Experience with working in eTMF and CTMS within the framework of the study start up responsibilities.